A Randomised, Double-blind, Placebo-controlled Multi-centre Study to Investigate the Effectiveness and Safety of STW5-II as add-on Treatment for Induction of Remission in Patients With Mild to Moderate Ulcerative Colitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Bayer
- 入组人数
- 3
- 主要终点
- Number of patients who reached a remission at least once during the course of the study
研究概览
简要总结
The study will investigate efficacy of STW5-II as add-on therapy on the rate to remission in patients with mild to moderate ulcerative colitis in an acute flare.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with mild to moderate active ulcerative colitis (UC), i.e. Clinical Activity Index (CAI) ≥ 5 up to 10 points (including)
- •Patients in whom the active UC is treated independent from any participation in the current study with oral mesalazine at least 14 days up to maximal 28 days before Visit 2
- •Age between 18 to 80 years (including)
- •UC may reach from left-sided colitis to pancolitis
排除标准
- •Severe forms of UC (CAI > 10)
- •Crohn's disease, infectious colitis or undetermined colitis
- •Steroid dependence and steroid resistance
- •Concomitant medication with oral steroids, oral or topic budesonide, biologicals, immune modifiers, immunosuppressants
- •Antibiotics at screening visit, during the course of the study a short-term use in non-colitic afflictions is allowed, and is documented
- •Prior medication with biologicals, immune modifiers and immunosuppressants < 3 month wash-out
- •Total colectomy
- •Known allergies to components of STW5-II
- •Severe allergic diathesis
- •Topical mesalazine application
- •Known intolerance to azo dyes E110 and E151
研究组 & 干预措施
STW5-II
Half of study population, assigned randomly
干预措施: STW5-II (Iberogast N, BAY98-7410) (Drug)
Placebo
Half of study population, assigned randomly
干预措施: Placebo (Drug)
结局指标
主要结局
Number of patients who reached a remission at least once during the course of the study
时间窗: Week 12
Proportion of patients being in remission at final visit
时间窗: Week 12
Responder definition for remission: Clinical Activity Index (CAI) ≤ 4
Change of endoscopic index (EI)
时间窗: From baseline to week 12
Change of histological index (HI) based on Riley
时间窗: From baseline to week 12
Proportion of patients reaching a clinical CAI ≤ 2 points
时间窗: Week 12
Time to remission, defined as days from Day 0 until first remission is reached
时间窗: Up to 12 weeks
Responder definition for remission: Clinical Activity Index (CAI) ≤ 4
Time to sustained remission (CAI ≤ 2 points) defined as days from Day 0 until first sustained remission is reached
时间窗: Up to 12 weeks
Number of patients who reached a sustained remission at least once during the course of the study
时间窗: Week 12
Change from baseline of absolute CAI values to final visit
时间窗: From baseline to week 12
Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ-D) (German version) at final visit
时间窗: From baseline to week 12
Change from baseline in Irritable Bowel Severity Score (IBSS) at final visit
时间窗: From baseline to week 12
Change from baseline in EuroQol 5 dimensions questionnaire (EQ-5D) at final visit
时间窗: From baseline to week 12
Mayo Score throughout the study
时间窗: Up to 12 weeks
Change of of oral mesalazine dose throughout the study period
时间窗: From baseline to week 12
Change in ulcerative colitis (UC) markers
时间窗: From baseline to week 12
Combination of four markers C-reactive protein (CRP), calprotectin, lactoferrin, polymorphonuclear (PMN) elastase for determination of parameters associated with acute flare of UC patients
次要结局
未报告次要终点